<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200307046715N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-14</date_registration>
      <primary_sponsor>Mitropoleos 92 St</primary_sponsor>
      <public_title>Impact of diet plus exercise on endothelial function, arterial stiffness and blood pressure in stage 1 hypertensive patients: results from the ΗINTreat randomized, open-label trial</public_title>
      <acronym>HINTreat</acronym>
      <scientific_title>ΗINTreat</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2637-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>91</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/46451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of participants to either the intensive lifestyle intervention treatment or the usual care group, was performed on blocks of 1, using the StatTrek software. Investigators, participants and statisticians were all aware of the allocation at every step of the progress, Blinding description: Participants were not aware of the group allocation or of the existence of other groups with different treatment protocols. Each participant performed the baseline and follow-up measurements alone, therefore no contact was performed with other participants. None of the examiners provided information on the two different treatments to the participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: receiving intensive lifestyle treatment concerning nutrition modification and exercise, in accordance with the ESH guidelines. In further detail, at baseline, the intervention group received a one-to-one a one hour nutrition education session with a registered dietitian, and a personalized diet plan. Emphasis was given on the dietary changes needed to be adhered, including an increase in fruit and vegetables consumption, a reduction in the salt intake, the effects of weight loss and the need for regular physical activity. Intervention 2: Control group: receiving baseline standard advise concerning lifestyle modifications, according to the ESH guidelines, without having a personalized diet plan or nutrition education sessions.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is participants might be identified</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anastasios Vamvakis</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>mitropoleos</address>
        <city>thessaloniki</city>
        <country1>Greece</country1>
        <zip>54624</zip>
        <telephone>+30 231 022 7623</telephone>
        <email>tvamvakis@yahoogr</email>
        <affiliation>aristotle university of thessaloniki</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anastasios Vamvakis</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mitropoleos</address>
        <city>Thessaloniki</city>
        <country1>Greece</country1>
        <zip>54624</zip>
        <telephone>+30 231 022 7623</telephone>
        <email>tvamvakis@yahoogr</email>
        <affiliation>Aristotle University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Greece</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Untreated stage 1 hypertensive
Adults
Agreed to participate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosis of secondary hypertension
Diabetes Mellitus
Cardiovascular Diseases
Any known inflammatory condition
Malignancy
Other significant comorbidities affecting blood pressure
Treatment with anti hypertensive agents or other significant medication including diuretics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: receiving intensive lifestyle treatment concerning nutrition modification and exercise, in accordance with the ESH guidelines. In further detail, at baseline, the intervention group received a one-to-one a one hour nutrition education session with a registered dietitian, and a personalized diet plan. Emphasis was given on the dietary changes needed to be adhered, including an increase in fruit and vegetables consumption, a reduction in the salt intake, the effects of weight loss and the need for regular physical activity.</i_keyword>
      <i_keyword>Control group: receiving baseline standard advise concerning lifestyle modifications, according to the ESH guidelines, without having a personalized diet plan or nutrition education sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: baseline, 3 months, 6 months. Method of measurement: sphygmomanometer.</prim_outcome>
      <prim_outcome>Carotid intima-media thickness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.</prim_outcome>
      <prim_outcome>Carotid stiffness. Timepoint: baseline, 6 months. Method of measurement: ultrasound.</prim_outcome>
      <prim_outcome>Pulse wave velocity. Timepoint: baseline, 6 months. Method of measurement: ABPM, Mobil-O-Graph.</prim_outcome>
      <prim_outcome>Lipid profile (Total Cholesterol, TG, HDL, LDL). Timepoint: baseline, 6 months. Method of measurement: Fasting blood sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anthropometry changes (body weight, waist &amp; hip circumference, body synthesis). Timepoint: baseline, 6 months. For body weight and circumferences also at 3 months. Method of measurement: weight scale, measuring tape, bioelectrical impedance.</sec_outcome>
      <sec_outcome>Physical activity level. Timepoint: baseline, 6 months. Method of measurement: IPAQ, pedometer.</sec_outcome>
      <sec_outcome>Diet changes. Timepoint: baseline, 6 months. 24 hour recall used at 3 months. Method of measurement: (3day recall, 24hour recall, MedDiet score, DII score, salt score).</sec_outcome>
      <sec_outcome>Urinary losses in sodium, potassium, creatinine, microalbumin. Timepoint: baseline, 3 &amp; 6 months. Method of measurement: 24h urinary sample analysis.</sec_outcome>
      <sec_outcome>Resting energy expenditure. Timepoint: baseline, 6 months. Method of measurement: Indirect calorimetry (Breezing).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mitropoleos 92 St</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2637-06-13</approval_date>
        <contact_name>Aristotle University |Ethical Committee</contact_name>
        <contact_address>University Campus Thessaloniki Thessaloniki Greece</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
